AccessGUDID - DEVICE: KELYNIAM CSI (00810125927355)

GUDID

Device Identifier (DI) Information

Brand Name: KELYNIAM CSI
Version or Model: PEEK-IM1004
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PEEK-IM1004
Company Name: KELYNIAM GLOBAL, INC.

Primary DI Number: 00810125927355
Issuing Agency: GS1
Commercial Distribution End Date: June 23, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 785088829 *Terms of Use

Device Description: PEEK Customized Cranial Implant, X-LARGE CSI061125-NK1

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46268	Cranioplasty plate, non-alterable	An implantable shield designed to repair larger skull defects that is preformed before surgery and typically made of sheets of material [e.g., stainless steel, vitallium, titanium (Ti), plastic resins] that cannot be reshaped at the time of surgery without changing the physical or chemical properties of the material. The device is generally preformed with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult skull; it is usually fixed to the intact cranial bones using screws and/or other fasteners. The device is used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GXN	Plate, Cranioplasty, Preformed, Non-Alterable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K103582	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5a947243-fc41-49ce-b516-8034c037635f
Public Version Date: July 01, 2025
Public Version Number: 1
DI Record Publish Date: June 23, 2025